QC LCM/Stability Lead

Guerbet; North Carolina; On-site; USD 150,000 - 190,000; Full time

Job summary

Guerbet is seeking a QC LCM/Stability Lead to drive analytical method validation and stability programs in a cGMP setting in the United States. You will serve as SME during FDA/EMA inspections, lead method lifecycle management, and mentor junior staff to uphold data integrity and regulatory compliance.

Responsibilities include designing validation protocols, interpreting results, and guiding CAPA activities while collaborating with QA, Regulatory Affairs, Manufacturing, and R&D to support

Qualifications

• Bachelor's degree in Chemistry or related scientific field with 10+ years of experience, or Master's degree with 5+ years of experience, or PhD with 2+ years of experience.
• Extensive experience in analytical method validation within a cGMP-regulated pharmaceutical environment.
• Strong knowledge of regulatory expectations and guidelines (cGMP, ICH Q2, Q1A, USP requirements).
• Experience with analytical techniques (e.g., HPLC, GC, dissolution, spectroscopy).
• Experience with laboratory systems (e.g., LIMS, Empower, CDS) and understanding of data integrity principles (ALCOA+)
• Strong problem-solving skills and ability to make sound technical decisions
• Excellent written and verbal communication skills with the ability to work with cross-functional teams

Responsibilities

• Leads and owns the analytical method validation strategy across products, ensuring alignment with regulatory expectations and business objectives
• Serves as Subject Matter Expert (SME) during regulatory inspections and audits (FDA, EMA), including preparation, defense of methodologies, and response to observations
• Provides technical leadership, coaching, and mentorship to junior analysts and scientists, fostering development and compliance culture
• Reviews, approves, and ensures the scientific integrity of validation protocols, reports, and associated documentation
• Designs, authors, and oversees execution of analytical method validation and verification protocols, including accuracy, precision, specificity, linearity, range, and robustness assessments
• Interprets and approves validation data, ensuring compliance with data integrity (ALCOA+) principles and regulatory requirements
• Establishes and enforces standards for identification, documentation, and escalation of deviations, OOS, OOT, or atypical results
• Leads complex investigations into method-related quality issues, drives root cause analysis, and ensures implementation of appropriate corrective and preventive actions (CAPA)
• Owns analytical method lifecycle management, including method transfer, continuous improvement, periodic review, and change control assessment
• Ensures laboratory systems, instrumentation, and processes supporting method validation are compliant, qualified, calibrated, and audit-ready
• Drives compliance with cGMP, ICH (Q2, Q14 as applicable), and global regulatory expectations, always ensuring inspection readiness
• Partners cross-functionally with QA, Regulatory Affairs, Manufacturing, and R&D to support product development, regulatory submissions, and commercial lifecycle activities

Skills

Analytical method validation

Regulatory knowledge (cGMP, ICH Q2, Q1

Cross-functional collaboration

Problem solving

Communication skills

Education

Bachelor's degree in Chemistry or related scientific field

Master's degree in Chemistry or related field

PhD in a related field

Tools

LIMS

Empower

CDS

Job description

The QC LCM/Stability Lead will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization's framework, company's procedures, and the defined scope of responsibility the role is accountable for.

The LCM / Validation & Stability Chemistry Lead is responsible for providing technical leadership and oversight of analytical method validation and stability programs to ensure product quality and regulatory compliance. This role serves as a Subject Matter Expert (SME) supporting regulatory inspections, lifecycle management, and cross-functional initiatives in a cGMP-regulated environment.

YOUR ROLE

• Leads and owns the analytical method validation strategy across products, ensuring alignment with regulatory expectations and business objectives
• Serves as Subject Matter Expert (SME) during regulatory inspections and audits (FDA, EMA), including preparation, defense of methodologies, and response to observations
• Provides technical leadership, coaching, and mentorship to junior analysts and scientists, fostering development and compliance culture
• Reviews, approves, and ensures the scientific integrity of validation protocols, reports, and associated documentation
• Designs, authors, and oversees execution of analytical method validation and verification protocols, including accuracy, precision, specificity, linearity, range, and robustness assessments
• Interprets and approves validation data, ensuring compliance with data integrity (ALCOA+) principles and regulatory requirements
• Establishes and enforces standards for identification, documentation, and escalation of deviations, OOS, OOT, or atypical results
• Leads complex investigations into method-related quality issues, drives root cause analysis, and ensures implementation of appropriate corrective and preventive actions (CAPA)
• Owns analytical method lifecycle management, including method transfer, continuous improvement, periodic review, and change control assessment
• Ensures laboratory systems, instrumentation, and processes supporting method validation are compliant, qualified, calibrated, and audit-ready
• Drives compliance with cGMP, ICH (Q2, Q14 as applicable), and global regulatory expectations, always ensuring inspection readiness
• Partners cross-functionally with QA, Regulatory Affairs, Manufacturing, and R&D to support product development, regulatory submissions, and commercial lifecycle activities

YOUR BACKGROUND

Required Qualifications

• Bachelor's degree in Chemistry or related scientific field with 10+ years of experience, or Master's degree with 5+ years of experience, or PhD with 2+ years of experience
• Extensive experience in analytical method validation within a cGMP-regulated pharmaceutical environment
• Strong knowledge of regulatory expectations and guidelines (cGMP, ICH Q2, Q1A, USP requirements)
• Experience with analytical techniques (e.g., HPLC, GC, dissolution, spectroscopy)
• Experience with laboratory systems (e.g., LIMS, Empower, CDS) and understanding of data integrity principles (ALCOA+)
• Strong problem-solving skills and ability to make sound technical decisions
• Excellent written and verbal communication skills with the ability to work with cross-functional teams

Preferred Qualifications

• Proven experience leading validation activities, investigations, and lifecycle management
• Advanced knowledge of evolving guidelines (e.g., ICH Q14)
• Advanced or specialized expertise in analytical techniques
• Demonstrated leadership capabilities (mentoring, project ownership, team influence)
• Experience interfacing directly with regulatory agencies